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Race and ethnicity in biomedical literature: A narrative review - Volume 31, Issue

Race and ethnicity are not clearly defined in biomedical literature and misaligned with genomics and epigenomic findings; the guidelines for consistent reporting in publications and regulations from health authorities are lacking. Minority…

Optimizing the value of regulatory writers - Volume 31, Issue

An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly…

Value of medical writing: The regulatory writer's perspective - Volume 31, Issue

The American Medical Writers Association formed a working group in 2020 focused on understanding and communicating the value that regulatory medical writers contribute to project teams, companies, and the wider research community. The working…

From the Editor - EMWA and Medical Writing: 12 months into the pandemic - Volume 30, Issue

What a year! A year of corona, crisis, and challenges. But also a year of innovations, break - throughs, and opportunities. I am one to focus on silver linings and here are some to think about. I am immensely proud of being part of an industry that…

News from the EMA - Volume 31, Issue

EMA is putting in place special support to developers to replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines. The Agency is promoting these three principles replace, reduce and…

My First Medical Writing - Volume 28, Issue

In this edition of My First Medical Writing, we welcome one of the first articles written by aspiring medical writer Mayya Sundukova. A physicist by training, Mayya pursued her PhD in neuroscience in SISSA, Italy, studying ion channels, and then…

How mentorship has created a special community and helped people develop their careers - Volume 30, Issue

Mentorship is an extremely rewarding relationship between two people with the goal of professional and personal development. Elemed’s Mentoring Academy in partnership with the Regulatory Affairs Professional Society (RAPS) combines three pillars –…

Translating “medicalese”: The case of informed consent forms - Volume 33, Issue

Informed consent forms (ICFs) are documents used in clinical research to inform prospective participants about – and obtain their consent for – partaking in a clinical trial. Evidence suggests that ICFs may not be fit for purpose because their…

Veterinary Medical Writing - Volume 33, Issue

Section Editor: Louisa Marcombes Spotlight on www.LAS-interactive.de: Information for animal experimentation and a useful resource for veterinary medical writers Authors: Cemile Jakupoglu, Jennifer Freymann According to the EU Animal Protection…

Essential investments in optimising clinical research for rare disease - Volume 34, Issue

The complexities associated with clinical trials for (ultra) rare diseases include regulatory and logistical hurdles and the challenge of building trusting relationships with health authorities, patients, and clinicians. Significant obstacles…

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Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.

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